Healthy Participants Will Take One Dose of a Drug After Eating a Meal, Then Test for Drowsiness and Fall Risk With Brain Wave Monitoring Throughout the Testing. Participants Will Take a Second Dose of the Drug With the Same Testing.
Healthy Participant Comparison Between 2 Different Doses of Metaxalone to Measure Drowsiness, Cognition and Fall Risk
Investigational drug(s) / intervention(s)
Metaxalone 640 mgMetaxalone 800 MG
Metaxalone 640 mg: Dose micronized 640 mg
Metaxalone 800 MG: The dose is 800 mg
Study summary
Health participants take a single dose, perform testing, washout for one week, take a single dose of different formulation, and perform testing for comparison of the 2 doses.
Eligibility
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* Healthy adults aged 18 to 55 years old
* Weigh at least 120 pounds
* Medically healthy
* Able to sign and date informed consent form
Exclusion Criteria:
* Current use of any medications known to affect the sleep-wake cycle
* Sleep disorder diagnosis
* Positive urine test for drugs
* Known history of alcohol use disorder
* Having a history of cognitive disorders, depression, schizophrenia, panic disorder, or dementia
* Having difficulty eating high fat meal
* Participants who are pregnant, nursing or intending to become pregnant during the period of study.
* Blood Pressure \> 160/110 or \<90/50 mmHg.
* Heart Rate \>100 or \< 50/ beats per minute.
* Having a history of seizure disorder or epilepsy.
Primary outcome measure(s)
Change from baseline to approximately 4 hours post-dose, in mean reaction time to a stimulus as measured in milliseconds by the Reaction Time Test (RTT) — Baseline dose to four (4 ) hours post-dose
Change from baseline to approximately 4 hours post-dose of delayed response exceeding a predefined threshold >300 ms as measured by the Reaction Time Test (RTT) — Baseline dose to approximately 4 hours post-dose
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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